Think Surgical gains clearance for total knee replacement system

The FDA provided Think Surgical 510(k) clearance to market its TSolution One total knee application for total knee arthroplasty in the U.S.

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Four insights:

1. TSolution One features 3D preoperative surgical planning technology, enabling surgeons to prepare a virtual plan for patients’ knee replacement procedures.

2. Five surgeons participated in the clinical trial, which achieved 100 percent retention of the 115 enrolled patients.

3. Think Surgical is a client of MCRA, a medical device advisory firm and clinical research organization.

4. MCRA provided clinical study management support and assisted Think Surgical in submitting the device’s IDE to the FDA.

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